FDA Adverse Event
Injury
Summary report: N
PRODISC-C IMPLANT MEDIUM 5MM-STERILE
MDR report key: 2900148
·
Received January 7, 2013
Report
- Report Number
- 2530088-2013-00011
- Event Type
- Injury
- Date Received
- January 7, 2013
- Report Date
- December 10, 2012
- Manufacturer
- SYNTHES BRANDYWINE
- Product Code
- MJO
- PMA / PMN Number
- P070001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE REPORTED DATE OF IMPLANT WAS APPROXIMATELY 6 TO 10 MONTHS AGO ((B)(6) 2012). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. PLACEHOLDER.
Description of Event or Problem · 1
PATIENT WAS IMPLANTED WITH PRODISC-C IMPLANT ON AN UNKNOWN DATE APPROXIMATELY 6 TO 10 MONTHS AGO ((B)(6) 2012). PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012, FOR REVISION SURGERY DUE TO THE PRODISC-C IMPLANT SUBSIDING TO THE BONE. PATIENT WAS REVISED TO A ONE LEVEL ACDF WITH VECTRA X CCACF. REPORTEDLY WHEN THE PRODISC-C IMPLANT WAS INITIALLY IMPLANTED, EVERYTHING WAS FINE AND ALMOST LOOKED PERFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 8180 | PRODISC-C IMPLANT MEDIUM 5MM-STERILE | PRODISC-C | MJO | SYNTHES BRANDYWINE | 6545131 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |